Kornimate/medical-research-clean huggingface dataset:
minocycline in clinically isolated syndromes (cis)

Conditions: Clinically Isolated Syndromes; Early Single Relapse of Multiple Sclerosis

Summary: the aim of the trial is to demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of cis to mcdonald criteria ms (mcdms) by an absolute 25% as compared to placebo, over a 6 month follow-up period (primary outcome). a key secondary outcome is to confirm that this early treatment benefit is maintained at two years.

* minocycline 100 mg bid orally compared to identical placebo * clinically isolated syndrome (cis): patients with a first clinical demyelinating event suggestive of multiple sclerosis (at baseline participants may meet 2010 mcdonald diagnostic criteria for ms, but not 2005 criteria) * men and women, aged 18-60y, first event within the previous 180 days; brain magnetic resonance imaging (mri) with at least two brain t2 lesions which are at least 3 mm in diameter, and at least one of which is ovoid or periventricular or infratentorial. * up to 24 months of study drug (up to 12 months of study drug for patients recruited after december 31, 2012) * patients will be discontinued from the study when they convert to mcdms based on the 2005 mcdonald definition. * 12 canadian ms clinics * a total of 154 patients will be randomized. because 30% of screened patients with cis who are clinically eligible are not expected to meet the mri criteria for inclusion, up to 280 patients will be screened.

Eligibility criteria:
inclusion criteria: * age between 18 and 60 years. * first focal clinical episode suggestive of demyelinating disease within the previous 180 days (measured from onset of the first symptom to treatment start), based on the appearance of a neurological abnormality, present for at least 24 hours. * objective clinical evidence must be present or documented. patients will be included irrespective of whether the first clinical demyelinating episode was monosymptomatic (i.e. clinical evidence of a single lesion) or polysymptomatic (i.e. clinical evidence of more than one lesion). * at least two lesions on the t2-weighted brain mri\* scan at least one of which is ovoid or periventricular or infratentorial. mri eligibility will be determined centrally by the ubc ms/mri research group.\*one lesion on spinal mri may substitute for one brain lesion as per the 2005 mcdonald criteria. * sexually active women of child-bearing potential must agree to use adequate contraception. * written informed consent exclusion criteria: * any disease other than ms that could better explain the patient's signs and symptoms. * any previous clinical event reasonably attributable to acute demyelination, regardless of whether medical attention was obtained. * complete transverse myelitis or bilateral optic neuritis. a waiver can be obtained for bilateral optic neuritis but must be obtained prior to randomization. waivers must be approved by 3 neurologists including a member of the clinical eligibility / endpoint committee, a member of the dsmc, and by an experienced ms neurophthalmologist.

Keywords: multiple sclerosis clinically isolated syndrome minocycline placebo
imatinib mesylate and cyclophosphamide in metronomic administration: dose escalation study of imatinib mesylate

Conditions: Cancer

Summary: the purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).


Eligibility criteria:
inclusion criteria: * rare tumor * metastatic disease or locally advanced disease, inoperable, with no standard treatment * at least 28 days since the prior treatment * measurable disease with at least one measurable lesion exclusion criteria: * medullary insufficiency * cystitis, haemorrhagic cystitis * hepatic porphyria

Keywords: dermatofibrosarcoma cylindroma choroid melanoma gastrointestinal stroma tumor chordoma ocular melanoma conjunctival melanoma malignant melanoma of the anus gastric melanoma desmoid tumor
recurrence rate comparison between esomeprazole and lansoprazole in eradicating helicobacter pylori infection among children

Conditions: Helicobacter Pylori Infection

Summary: this study aims to compare the recurrence rates of esomeprazole and lansoprazole in triple combination therapy to eradicate h.pylori infection in children. the participants were divided into two groups, those who received esomeprazole and those who received lansoprazole

h. pylori eradication therapy is still contentious. a treatment that is uncomplicated, well-tolerated, and boasts an efficiency rate of more than 80% is recommended. ppis are a type of acid-sensitive drug which is most beneficial in preventing the degradation of drugs in the stomach. in developing countries, esomeprazole and lansoprazole were mainly selected as a drug of choice. major influential factors such as esomeprazole's additional antioxidant ability, are comparable to vitamin c. this is due to its ability to scavenge diphenyl picrylhydrazyl (dpph) free radicals at low concentrations. lansoprazole also possess similar ability, albeit needs a slightly higher concentration to reach a similar effect. in terms of ic50 values, both drugs have a substantial advantage over vitamin c, earning them the title of 'potentially ideal' agents in the treatment algorithm. furthermore, numerous studies mention that children better tolerate ppis.

Eligibility criteria:
inclusion criteria: * subject has positive clinical symptoms (gastrointestinal pain, nausea, vomiting, hematemesis, or melena) * subject had been diagnosed with h.pylori infection prior to endoscopy and rapid urease testing exclusion criteria: * subject has a history of using antibiotics or non-steroidal anti-inflammatory medicines (nsaids) within 14 days prior to surgery * subject has a concomitant systemic disease (e.g., renal failure, liver cirrhosis, cancer, etc.) that could theoretically affect the subject's response to treatment * incomplete triple pharmacologic treatment due to the subject's lack of medication adherence

Keywords: helicobacter pylori triple therapy children esomeprazole lansoprazole
icu venous thromboembolism incidence study in a chinese population

Conditions: Venous Thromboembolism

Summary: venous thromboembolism (vte) is one of the major public health problems in western country. more than 100,000 americans die each year from vte. vte is also a common complication of critical illness,1-2 and probably related to poor outcome in this patient group. although there are guidelines about vte prophylaxis in acutely ill medical patients and patients in medical icu3, they are overlooked in our daily practice frequently in our country. there are many reasons for our common practice, including inadequate knowledge for the icu physicians, more patients with bleeding tendency in icu and low prevalence of vte in our (eastern) country. however, the true prevalence of vte in icu and if thromboprophylaxis still needed in certain high risk patients are not unknown. besides, if there is a difference in the vte rate between western and eastern patients, what is the underlying mechanism? the major objective of this application is to answer the first part of the problem, i.e. to delineate the scope of this problem. the specific aims of this application are as follows: * prevalence of venous thromboembolism in icu in taiwan * specific risk in subgroups of icu patients * prevalence and risk factors for silent pulmonary embolism


Eligibility criteria:
inclusion criteria: * all patients admitted to medical icu with age over 18 y/o are eligible exclusion criteria: * patients who do not sign the informed consent will be excluded from this study

Keywords: patient in critical care
comparing treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in copd patients

Conditions: Percentage of Annual Acute Exacerbation; Quality of Life

Summary: this study is to investigate and compare treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in copd patients.

diagnosis and criteria for inclusion and exclusion: inclusion: 1. male or female outpatients aged 40 years≧ 2. current or ex-smoker, with smoking history 10 pack≧- years 3. copd (fev1/fvc \< 70%) patients with post-bronchodilator fev1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator) exclusion: 1. diagnosis or suspicion of sleep apnea. 2. concurrent rhinitis, eczema, and asthma. 3. clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease. 4. a chest x-ray indicating diagnosis other than copd that might interfere with the study. 5. major disease abnormalities are uncontrolled on therapy. 6. alcohol or medication abuse. 7. patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study. 8. unable or unwilling to comply with all protocol test product: fluticasone125 mcg/salmetrol 25 mcg ( seretide 125 evohaler ) fluticasone250 mcg/salmetrol 25 mcg ( seretide 250 evohaler ) formulation: fluticasone/salmeterol, 125/25 mcg/puff dose: 2 puffs bid

Eligibility criteria:
inclusion criteria: 1. male or female outpatients aged 40 years≧ 2. current or ex-smoker, with smoking history 10 pack≧- years 3. copd (fev1/fvc \< 70%) patients with post-bronchodilator fev1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator) exclusion criteria: 1. diagnosis or suspicion of sleep apnea. 2. concurrent rhinitis, eczema, and asthma. 3. clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease. 4. a chest x-ray indicating diagnosis other than copd that might interfere with the study. 5. major disease abnormalities are uncontrolled on therapy. 6. alcohol or medication abuse. 7. patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study. 8. unable or unwilling to comply with all protocol

Keywords: copd fluticasone/salmeterol high dose
combined postoperative radiotherapy with kidney sparing surgery for locally advanced high-risk ureteral cancer

Conditions: Locally Advanced; Urothelial Carcinoma Ureter

Summary: in this study, we propose to conduct an ambispective study to analyze the safety of preserved renal unit surgery combined with postoperative adjuvant radiotherapy in patients with limited stage ureteral cancer with high risk factors, and the efficacy analysis compared with traditional radical surgery. it is hoped that a treatment method that preserves patients' renal function to improve the tolerance of subsequent drug therapy without decreasing the effect of tumor treatment can be achieved in patients with high-risk factors.


Eligibility criteria:
inclusion criteria: - 1) ureteral cancer patients with high-risk factors (high-risk factors define multifocal; g3; t2-4); surgery may be performed with patients undergoing partial terminal ureteral resection or radical nephroureterectomy 2)age ≥18 years; 3)completion of abdominopelvic ct 4 weeks before enrollment to exclude distant metastasis and regional lymph node metastasis. 4) patients did not have other malignant neoplastic diseases in the last 5 years except for non-melanoma of the skin and ductal carcinoma in situ of the breast; willing to participate in perfecting the necessary examinations and follow-up for the sake of the study, and willing to provide written informed consent. exclusion criteria: * 1) distant metastasis or retroperitoneal lymph node metastasis (n+) had been detected at the time of surgery; r2 resection patients; history of bladder cancer; 2) history of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; 3) pregnant women or breastfeeding women; or women of childbearing potential who are not practicing reliable contraception; (4) the presence of active infections in those with pre-existing or coexisting bleeding disorders 5) clinically significant cardiac disease (e.g., hypertension controlled with medications, unstable angina, new york heart association (nyha) class ≥ii congestive heart failure, unstable symptomatic arrhythmias, or class ≥ii peripheral vascular disease); 6) psychological, family, and social factors leading to lack of informed consent.

Keywords: upper tract urothelial carcinoma radiotherapy kidney sparing surgery locally advanced ambispective cohort
evaluation of the safety and effectiveness of direct-acting antiviral drugs in the treatment of hepatitis c in patients with inflammatory bowel disease: national multicenter study

Conditions: Inflammatory Bowel Diseases; Hepatitis C Virus Infection

Summary: the prevalence of hepatitis c virus infection (hcv) in patients with inflammatory bowel disease (ibd) ranges from 1-6%. direct-acting antivirals (daas), with cure rates \>90%, represent a radical change from interferon-based therapies. the ecco (european crohn's and colitis organisation) guidelines (kucharzik t, ellul p, greuter t, et al. ecco guidelines on the prevention, diagnosis, and management of infections in inflammatory bowel disease. j crohn's colitis. 2021;15(6):879-913) warns about the risk of ibd reactivation due to the effect of daas, but hcv management in this situation is uncertain given the lack of evidence. the project is proposed as the largest retrospective multicenter descriptive study carried out to evaluate the use of daas for hcv eradication in patients with ibd. the eneida database (zabana y, panés j, nos p, et al. the eneida registry (nationwide study on genetic and environmental determinants of inflammatory bowel disease) by geteccu: design, monitoring, and functions. gastroenterol y hepatol. 2020;43(9):551-8.) of the spanish working group on crohn's disease and ulcerative colitis (geteccu) is an adequate registry to identify patients with hcv infection. the serological status of the infection is frequently recorded in the eneida database, and it is generally evaluated at the time of ibd diagnosis, before starting immunosuppressive treatment. the eneida registry has the advantage over large population studies that researchers have access to relevant details of the clinical history, which can respond to the controversies raised. this multicenter retrospective descriptive study will provide useful information to be able to give evidence-based recommendations regarding treatment of hcv in patients with ibd.

hypothesis: the use of daas for hcv eradication in patients with ibd is effective and safe. daas do not trigger ibd flares. daas probably do not present serious pharmacological interactions, with clinically relevant, with immunosuppressants and/or biological agents.

Eligibility criteria:
inclusion criteria: * all individuals diagnosed with ibd according to the ecco criteria and chronic hcv infection (positive hcv ab and detectable rna) treated with daas and/or interferon collected in the eneida database, and who have properly completed the fields of age, gender, treatment, location, and phenotype of ibd, will be included in the study. * study period: patients treated with daas between january 1, 2011 - february 28, 2021. exclusion criteria: * spontaneous cure of hcv without treatment * hcv treatment outside the study period.

Keywords: inflammatory bowel diseases hepatitis c virus infection direct-acting antiviral drugs
absolute bioavailability, safety, and tolerability of subcutaneous gs-5745 in healthy adults

Conditions: Ulcerative Colitis

Summary: this study will estimate the absolute bioavailability of subcutaneously injected gs-5745, characterize the safety, tolerability, and pharmacokinetics (pk) of gs-5745 after subcutaneous (sc) injection and intravenous (iv) administration, and evaluate the formation of anti-gs-5745 antibodies after sc and iv administration.


Eligibility criteria:
inclusion criteria: * in the opinion of the investigator, individuals must be in good general health based upon medical history and physical examination * females, of childbearing potential, and males must agree to utilize protocol specific contraception methods * screening laboratory evaluations must be within defined thresholds exclusion criteria: * infection with hepatitis b virus (hbv), hepatitis c virus (hcv) or human immunodeficiency virus (hiv) * pregnant and lactating females * history of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual treatment and/or adherence to the protocol
a study of neoadjuvant bio-c/t followed by concurrent bio-r/t in high-risk locally advanced oral squamous cell carcinoma

Conditions: Oral Cancer

Summary: surgical resection followed by concurrent chemoradiotherapy is considered as the standard of care for locally advanced oscc (laoscc). although the treatment could provide prompt local control, but it is also associated with high incidence of distant failure. systemic chemotherapy given either before (neoadjuvant) or after (adjuvant) definitive local treatment has been extensively evaluated to improve the clinical outcome in laoscc. regimens of taxane/cisplatin-based combinations have been shown to improve the treatment outcome of patients with locally advanced head and neck squamous cell carcinoma (hnscc) in neoadjuvant setting. recently, cetuximab (erbitux®), a monoclonal antibody against epidermal growth factor receptor (egfr), has also been proven to be an efficient agent for advanced and/or refractory hnscc with acceptable toxicity profiles. in current study, we shall evaluate the feasibility, efficacy and safety of a triplet bio-chemotherapy consisting of cetuximab, paclitaxel, and cisplatin followed by cetuximab-based concurrent bio-radiotherapy (cbrt) in patients with laoscc.

patients with high-risk, locally advanced (txn2b\~3 or t4n0\~3, m0) oscc will be eligible. to detect an interested objective response rate (p1) of 80% versus a non-interested response (p0) rate of 60%, with an α and 1-β of 0.05 and 0.2, respectively (two-sided test), including the estimated dropout rate of 10%, a total of 47 patients will be recruited.

Eligibility criteria:
inclusion criteria: 1. high-risk, locally advanced (txn2b\~3 or unresectable t4, m0) oscc 2. histologically confirmed squamous cell carcinoma 3. performance status: eastern cooperative oncology group performance status (ecog) 0-1 4. age 18 years or older, less than 70 years of age 5. having signed informed consent 6. measurable disease by ct or mri 7. adequate hematologic, hepatic and renal function exclusion criteria: 1. prior radiotherapy for targeted lesions, chemotherapy, egfr pathway targeting therapy 2. prior surgery for cancer except for the purpose of diagnostic biopsy 3. concomitant active 2nd malignancies or disease-free of malignancies \< 3 years before the study except adequately treated in situ cervical cancer, or non-melanoma skin cancer 4. concomitant anticancer therapies within the past 28 days 5. severe cardiopulmonary diseases and other systemic disease under poor control 6. uncontrolled chronic neuropathy 7. women who are positive of pregnancy, or in breast-feeding 8. known allergy to any study treatment 9. legal incapacity 10. significant disease which, in the investigator's opinion, would exclude the patient from the study

Keywords: oral squamous cell carcinoma neoadjuvant bio-chemotherapy concurrent bio-radiotherapy biomarker
hdr vs ldr brachytherapy as monotherapy in the treatment of localized prostate cancer.

Conditions: Adenocarcinoma of Prostate

Summary: investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer patients.

permanent implant prostate brachytherapy (ldrpbt) is a well established and proved method in the treatment of patients with low or selected intermediate risk, organ confined prostate cancer. there are number of studies with high-dose rate brachytherapy (hdrpbt) as monotherapy with several fractionation schedule treating the same group of patients. one phase ii trial showed its effectiveness given in one fraction of 19 gy. in the trial investigators randomly select patients to treat with either ldr prostate brachytherapy (145gy) or hdr prostate brachytherapy (1x19gy) as monotherapy. patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate risk group. brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time treatment planning. dose constraints are defined for both methods.

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) status \<=1 * 40-75 years old * expected life expectancy\>10 years * low risk prostate cancer (prostate specific antigen (psa)\<=10ng/ml, gleason score \<7, t status\<=2a), less than 50 % positive biopsy cores * selected intermediate prostate cancer (psa)=10-\<15ng/ml or gleason score =3+4(but not 4+3), or t2b-c, less than 50 % positive biopsy cores) * international prostate symptom score (ipss) \<=15 * prostate volume\<=50cm3 * no pubic interference * no prior prostate operation, except biopsy * no prior radiation to pelvis * patient signed the informed consent exclusion criteria: * \ 75 years old * psa\>15 ng/ml gleason score 4+3 , score 8-10 * ecog\>=2 * t3-4 * percent core positivity \>50 % * tur operation within six months prior to the brachytherapy prostate volume\ 50 cm3 ipss \>15

Keywords: prostate, cancer, brachytherapy, hdr, ldr, monotherapy
a study of lanabecestat in participants with severe kidney impairment compared to healthy participants

Conditions: Renal Insufficiency

Summary: the purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment. participants will be on study for up to 6 weeks; this includes a 2-week screening and a follow-up about 10 days after final drug administration.


Eligibility criteria:
inclusion criteria: - have a body mass index (bmi) of 19 to 40 kilograms per meter square (kg/m²) exclusion criteria: * have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina * have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation * have acute unstable neuropsychiatric disease * have active or uncontrolled neurologic disease, or clinically significant head injury
role of curarization during anesthesia for laparoscopic hysterectomy

Conditions: Curarization, Postoperative Residual; Postoperative Pain Of Laparoscopic Surgery; PONV

Summary: the primary outcome of this study is to investigate whether deep nmb reversed with sugammadex is superior to moderate nmb reversed with neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic hysterectomy, reversal time from nmb (tof≥0.9) and direct and indirect costs. additionally we will also assess: drugs consumption for pain and antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability, operation time, anesthesia time, total amount and flow rate of co2, insufflation time, resolution of post-operative ileus, dry mouth and ponv in the first 48 hours, patient satisfaction.


Eligibility criteria:
inclusion criteria: age 18-75 years bmi between 16 and 40 kg/m2 ecog performance status tra 0 e 1 american society anesthesiologist (asa) class 1 or 3 able to provide informed consent to trial procedures exclusion criteria: * age \ 75 years * bmi \ 40 kg/m2 * ecog performance status \>1 * pregnancy * active or recent pelvic inflammation * anticipated airway difficulty * patients with history of allergy to rocuronium, neostigmine or sugammadex * allergy to nsaids * previous opioids consumption for chronic pain * patients receiving drugs for different medical conditions, that may prolong or shorten the duration of rocuronium effect (e.g aminoglycosides, magnesium) * hepatic or renal failure * persistent coagulopathy * neurological or cognitive disorders * conversion from laparoscopic to open surgery onset of intraoperative complications

Keywords: deep neuromuscular blockade sugammadex postoperative pain laparoscopic hysterectomy